Revalidation & Change Control – Pharma Validation

Managing Revalidation & Change Control in Pharma: Ensuring Ongoing Compliance Through Lifecycle Updates

Managing Revalidation & Change Control in Pharma: Ensuring Ongoing Compliance Through Lifecycle Updates Managing Revalidation & Change Control in Pharma: Ensuring Ongoing Compliance Through Lifecycle Updates 1. Introduction: Why Revalidation and Change Control Are Crucial Pharmaceutical validation is not a…

Routine, Periodic & Change-Triggered Revalidations in Pharma: What, When & Why Explained

Routine, Periodic & Change-Triggered Revalidations in Pharma: What, When & Why Explained Understanding Routine, Periodic, and Change-Driven Revalidations in Pharma Maintaining the validated state of pharmaceutical processes and systems is a regulatory imperative. Revalidation — whether routine, periodic, or change-triggered…

Identifying What Changes Demand Revalidation

Identifying What Changes Demand Revalidation How to Identify Which Changes Require Revalidation in Pharma In pharmaceutical manufacturing, maintaining a validated state is a fundamental requirement of GMP. As systems, processes, and equipment evolve, the question arises: which changes demand revalidation?…

Deciding When to Revalidate Using QRM Principles

Deciding When to Revalidate Using QRM Principles How to Decide When to Revalidate Using Quality Risk Management (QRM) Principles Revalidation in the pharmaceutical industry is essential for maintaining a consistent, GMP-compliant, and validated state of processes, systems, and equipment. However,…

Revalidation Protocols, Reports & Justifications

Revalidation Protocols, Reports & Justifications How to Document Revalidation in Pharma: Protocols, Reports & Justifications Explained In pharmaceutical validation, robust documentation is not just good practice — it’s a regulatory obligation. Whether you are performing revalidation due to a process…

FDA/EMA Expectations on Change Control & Revalidation: Ensuring Compliance Across the Lifecycle

FDA/EMA Expectations on Change Control & Revalidation: Ensuring Compliance Across the Lifecycle What FDA and EMA Expect from Pharma on Change Control and Revalidation Activities In the pharmaceutical industry, compliance doesn’t end after initial validation. The FDA and EMA both…

What Triggers Revalidation in Pharma? A Complete Guide

What Triggers Revalidation in Pharma? A Complete Guide What Triggers Revalidation in Pharma? A Complete Guide In the pharmaceutical industry, maintaining the quality and integrity of products is critical throughout their lifecycle. Process validation encompasses multiple stages, including design, qualification,…

Periodic Revalidation: Frequency, Requirements, and Templates

Periodic Revalidation: Frequency, Requirements, and Templates Periodic Revalidation: Frequency, Requirements, and Templates Periodic revalidation is an essential aspect of the lifecycle of process validation in the pharmaceutical industry. This article offers a comprehensive, step-by-step tutorial on the validation lifecycle, ensuring…

Revalidation After Process Changes: What Needs to Be Done

Revalidation After Process Changes: What Needs to Be Done Revalidation After Process Changes: What Needs to Be Done In the pharmaceutical industry, maintaining compliance with regulatory standards is paramount. The validation processes involved are vital to ensuring product quality and…

Product Change Revalidation Checklist for Multi-Product Facilities

Product Change Revalidation Checklist for Multi-Product Facilities Product Change Revalidation Checklist for Multi-Product Facilities In the pharmaceutical industry, process validation is a vital component that ensures the quality, safety, and efficacy of drug products. The transition from one product to…